KR20190129004A - Diagnosis of Systemic Lupus Erythematosus Using TCP1 Autoantibodies - Google Patents

Abstract

The present invention relates to a method for diagnosing systemic lupus erythematosus using antigenic proteins that specifically bind to TCP1 autoantibodies present in the blood of patients with systemic lupus erythematosus. Since the diagnostic method of the present invention uses a non-invasive biological sample such as blood, it is possible to diagnose systemic lupus erythematosus very simply without burdening the patient, unlike conventional diagnostic methods. The present invention also can be advantageously used for early diagnosis of systemic lupus erythematosus with high specificity and sensitivity.

Description

Diagnosis of Systemic Lupus Erythematosus Using TCP1 Autoantibodies}

The present invention relates to the diagnosis of systemic lupus erythematosus (SLE) using TCP1 (T-complex polypeptide 1) autoantibodies, and more specifically to specific binding to TCP1 autoantibodies present in the blood of patients with systemic lupus erythematosus. It relates to a method for diagnosing systemic lupus erythematosus using an antigenic protein.

Systemic lupus erythematosus (SLE) is an inflammatory reaction caused by autoimmunity in various tissues of the whole body. Skin rash, photosensitivity, arthritis, mouth ulcers, nephritis, cytopenia, vasculitis, and meningitis depending on the invading tissue And various symptoms. Systemic lupus erythematosus is known to be caused by certain viral infections or environmental exposures such as ultraviolet rays and smoking in people with genetic predisposition (Paula S et al., Semin Nephrol . 30 (2): 164-176, 2010; James JA et al., Opin Rheumatol . 8: 462-467, 2006).

The diagnosis of systemic lupus erythematosus is mainly based on the diagnostic criteria of the American Society of Rheumatology revised in 1997, which is defined as four or more cases out of 11 clinical criteria and immunological criteria including positive antinuclear antibody. There are no known biomarkers specific for lupus (Ahn JK et al., Korean J of Med , 78 (4): 409-415, 2010).

In the treatment of systemic lupus erythematosus, nonspecific drugs began to be used until the 1990s, and recently, cyclophosphamide is the most powerful drug used in urgent or severe inflammatory reactions such as nephritis and vasculitis, but sometimes infertility, severe infections, and hemorrhagic cystitis. Serious complications occur (M Petri et al., Lupus, 13: 366-371, 2004). In addition, steroids are the most rapid and potent inflammation-controlling agents when systemic lupus erythematosus is activated, but many patients are diagnosed with lupus at a young age, and the incidence of side effects from continuous administration of steroids due to repeated exacerbations is increased. (Susan D et al., Health and Quality of Life Outcomes, 15:43, 2017). There is no method for complete systemic lupus erythematosus yet, and there are various clinical findings and progression according to the patients. Therefore, the activity of the disease is judged and the presence or absence of other diseases such as infectious diseases is accurately determined. The appropriate treatment policy should be determined for the disease state.

Autoimmune diseases such as systemic lupus erythematosus are difficult to treat because there are no specific therapeutic agents to date, and unlike other diseases that can be eliminated with specific drugs, they cannot completely inhibit activated autoimmune cells. Therefore, biomarker research for early diagnosis, severity determination, and drug efficacy of systemic lupus erythematosus is very important, and it is very urgent to find biomarker of lupus through steady basic and clinical studies.

Accordingly, the present inventors have made efforts to find a biomarker that can easily diagnose systemic lupus erythematosus at an early stage without using biopsy or imaging technique. As a result, TCP1 (T-complex polypeptide 1) autoantibodies are specific for systemic lupus erythematosus. It was confirmed that the present in the blood, and completed the present invention.

An object of the present invention is to easily diagnose systemic lupus erythematosus using TCP1 autoantibodies present in the blood of patients with systemic lupus erythematosus, systemic lupus erythematosus comprising a composition for diagnosing systemic lupus erythematosus comprising TCP1 autoantibodies It is to provide a lupus diagnostic kit.

Another object of the present invention is to provide a method for detecting TCP1 autoantibodies in blood of a systemic lupus erythematosus patient and for diagnosing systemic lupus erythematosus by comparing TCP1 autoantibody levels with a control group.

In order to achieve the above object, the present invention provides a systemic lupus erythematosus (SLE) diagnostic composition comprising an antigen protein that specifically binds to TCP-T (complex polypeptide 1) autoantibodies.

The present invention also provides a kit for diagnosing systemic lupus erythematosus (SLE) comprising the composition.

The present invention also includes the steps of (a) detecting a TCP- (T-complex polypeptide 1) autoantibody in a biological sample isolated from the subject; And (b) provides a method for providing information for diagnosing systemic lupus erythematosus (SLE) comprising the step of comparing the detected TCP1 autoantibody level with the control.

Systemic lupus erythematosus diagnosis method using an antigen protein specifically binding to the TCP1 autoantibody of the present invention, because it uses a non-invasive biological sample such as blood, unlike the conventional method, very simple systemic lupus erythematosus Not only can be diagnosed but also high specificity and sensitivity can be useful for early diagnosis of systemic lupus erythematosus.

Figure 1 shows the systemic lupus erythematosus specific autoantibodies using 22K protein microarray.
Figure 2 shows the pCR8GW-TCP1 vector for the production of TCP1 recombinant protein expression vector.
Figure 3 shows the cloning results of the pCR8GW-TCP1 vector for the production of TCP1 recombinant protein expression vector.
4 shows the pDEST20-TCP1 vector for purification of TCP1 recombinant protein.
5 shows the cloning results of the pDEST20-TCP1 vector for purification of TCP1 recombinant protein.
Figure 6 confirms the expression of the GST-TCP1 recombinant protein.
Figure 7 shows the results of SDS-PAGE analysis of the purified GST-TCP1 recombinant protein.
Figure 8 shows the systemic lupus erythematosus specific autoantibodies using TCP1 recombinant protein and systemic lupus erythematosus clinical sample.
Figure 9 analyzes the specificity of systemic lupus erythematosus markers using TCP1 recombinant protein and systemic lupus erythematosus clinical sample.
Figure 10 is the analysis of the dot-blot assay results for specificity using the TCP1 recombinant protein and systemic lupus erythematosus clinical sample with the imageJ program.
FIG. 11 compares autoantibody detection specificity by performing a dot-blot assay in a systemic lupus erythematosus clinical sample using purified CTT3 protein and purified TCP1 recombinant protein as controls.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In general, the nomenclature used herein is well known and commonly used in the art.

In the present invention, in order to specifically diagnose systemic lupus erythematosus, attention was paid to autoantibodies, and the findings were verified. Accordingly, specific autoantibodies specific to systemic lupus erythematosus were identified using protein chips in which human antigens were integrated, and a TCP1 protein antigen capable of specifically binding to TCP1 autoantibodies was prepared. As a result of verifying the serum of systemic lupus erythematosus using the prepared TCP1 protein antigen, it was confirmed that the amount of TCP1 autoantibodies was present in the serum of systemic lupus erythematosus patients compared to the normal group.

Accordingly, the present invention relates to a composition for diagnosing systemic lupus erythematosus comprising an antigen protein that specifically binds to TCP1 autoantibodies in one aspect.

In the present invention, the TCP1 may be represented by the amino acid sequence of SEQ ID NO: 1. TCP1 is GenBank Accession No. It is preferable that it is the sequence of NM_030752.2.

As used herein, the term "autoantibodies (AAb)" refers to antibodies that are expressed in the body and specifically react with components in vivo.

In the present invention, the autoantibody may be an autoantibody against TCP1 produced at the onset of systemic lupus erythematosus.

The term "systemic lupus erythematosus (SLE)" of the present invention is a chronic autoimmune disease that causes inflammation of various organs such as skin, joints, kidneys, lungs and nerves due to abnormalities of the immune system that protects the human body from the outside. .

In another aspect, the present invention relates to a kit for diagnosing systemic lupus erythematosus comprising the above composition.

In the present invention, the kit may be characterized by diagnosing systemic lupus erythematosus by detecting TCP1 autoantibodies in a bodily fluid sample through an antigen-antibody binding reaction. That is, the systemic lupus erythematosus can diagnose its onset by detecting autoantibodies against TCP1 in the blood of the patient.

The term "diagnosis" of the present invention means confirming the presence or characteristic of a pathological condition. In the present invention, the diagnosis may be interpreted as confirming the development of systemic lupus erythematosus.

As used herein, the term “antigen” refers to a proteinaceous immunogen capable of performing antigen-antibody binding with an antibody, which is encoded by the marker gene by cloning each gene into an expression vector according to a conventional method. Proteins can be obtained and prepared from conventional proteins by conventional methods.

The antigen used in the present invention may be TCP1 described above.

The kit of the present invention can be used to diagnose the onset of systemic lupus erythematosus by measuring the level of autoantibodies against TCP1 from a sample derived from an individual suffering from systemic lupus erythematosus, but is not particularly limited thereto. Antigens, antibodies, aptamers, as well as one or more other constituent compositions, solutions or devices suitable for assays may be included for measuring

As used herein, the term "sample" refers to a direct subject which is isolated from an individual suffering from systemic lupus erythematosus and measures the level of expression of autoantibodies against TCP1, and preferably blood and serum of a patient suffering from systemic lupus erythematosus. , But is not limited to plasma.

In the present invention, the kit is preferably an enzyme immunoassay (ELISA), dot blot assay, or western blot assay kit, and the kit is not particularly limited, but is not particularly limited thereto. Substrates, suitable buffers, secondary antibodies labeled with chromophores or fluorophores, chromogenic substrates, and the like for physiological detection. The substrates are not particularly limited to 96 wells synthesized with nitrocellulose membranes and polyvinyl resins. Plates, 96-well plates synthesized with polystyrene resin, glass slides, etc. may be used, and chromase is not particularly limited, but peroxidase, alkaline phosphatase may be used, The fluorescent material is not particularly limited, but may be FITC, RITC, and the like, and the coloring substrate liquid is particularly limited thereto. Although not ABTS (2,2'- ahjino-bis (3-ethyl-benzothiazole-6-sulfonic acid sleepy)) can be a or OPD (o- phenylenediamine), TMB (tetramethylbenzidine).

Kits of the invention may include reagents, such as the reagents required to perform negative and positive control reactions or the buffers required for hybridization reactions. The optimal amount of reagent used in a particular reaction is readily available to those of ordinary skill in the art having read the disclosure. For example, the kit of the present invention may include the above-mentioned components in a separate package or compartment.

In still another aspect, the present invention provides a method for detecting a T-complex polypeptide 1 (TCP1) autoantibody in a biological sample isolated from a subject; And (b) relates to a method for providing information for diagnosing Systemic lupus erythematosus (SLE) comprising the step of comparing the detected TCP1 autoantibody level with the control.

In the present invention, the biological sample is not particularly limited thereto, and may be preferably blood, serum or plasma.

In the present invention, the term "detection" refers to a process of detecting and confirming an SMYD3 autoantibody in a biological sample through an antigen-antibody-binding reaction, using systemic leukemia using an antigen protein that specifically binds to the SMYD3 autoantibody. Lupus can be diagnosed. Western blotting, ELISA (enzyme linked immunosorbent assay), radioimmunoassay, radioimmunodiffusion, Ouchterlony immunodiffusion, and rocket immunoelectrolysis Electrophoresis, tissue immunostaining, immunoprecipitation assay, complement fixation assay, FACS, protein chip, etc., but are not limited thereto.

In the present invention, the TCP1 may be represented by the amino acid sequence of SEQ ID NO: 1.

In the method, if the level of autoantibody against TCP1 measured in the biological sample is significantly increased compared to the level measured from the biological sample in normal subjects, it may be determined that systemic lupus erythematosus occurs in the subject under test. If it does not increase significantly, it may be determined that systemic lupus erythematosus does not develop in the subject. In this case, the method for measuring the level of autoantibodies to TCP1 is the same as described above.

EXAMPLE

Hereinafter, the present invention will be described in more detail with reference to Examples. These examples are only for illustrating the present invention, and it will be apparent to those skilled in the art that the scope of the present invention is not to be construed as being limited by these examples.

Example 1: 22 K  protein Microarray  Utilized Systemic lupus erythematosus Autoantibodies  Sympathy

In order to detect systemic lupus erythematosus specific autoantibodies, serum samples of 5 normal and 10 systemic lupus erythematosus patients were tested using protein chips containing 22,000 (22K) human antigens. Antibodies were identified (FIG. 1).

Of these, 29 autoantibodies were from 4 patients, 10 autoantibodies were from 5 patients, 7 autoantibodies were from 6 patients, 6 autoantibodies were from 7 patients, 8 autoantibodies were from 8 patients Duplicates were detected from In particular, all three autoantibodies were detected in duplicate from the blood of nine systemic lupus erythematosus patients.

This is indicated by the systemic lupus erythematosus specific biomarker in Table 1 below.

Example 2: Preparation of systemic lupus erythematosus biomarker protein expression vector

An ENTRY vector was constructed containing the full domain of candidate TCP1 of systemic lupus erythematosus biomarker and named pCR8GW-TCP1.

In order to construct a pCR8GW-TCP1 construct, a primer was designed based on the full-length TCP1 DNA sequence (1671 bp), and then prepared by requesting macrogen (Table 2).

The amino acid sequence of the full-length TCP1 (aa 1-556) is shown in SEQ ID NO: 1, the TCP1 WT forward primer in Table 2 is shown in SEQ ID NO: 2, TCP1 WT reverse primer in SEQ ID NO: 3.

Human cDNA was used as a template and PCR was performed using the prepared primers. The synthesized PCR product was cloned into pCR8GW vector (FIGS. 2 and 3).

Then, the pDEST20-TCP1 construct was constructed by gateway cloning with the prepared vector to conjugate the GST-Tag to the TCP1 N-terminus (FIGS. 4 and 5). Using the vector produced by the amino acid sequence represented by SEQ ID NO: 1 was prepared TCP1-Bacmid capable of recombinant protein expression in insect cells.

Example  3: in Insect cells Systemic lupus erythematosus Biomarker  Expression of Recombinant Protein

TCP1-Bacmid prepared for expression of the recombinant protein of systemic lupus erythematosus biomarker TCP1 prepared in Example 2 was transfected into SF9 insect cells. Baculovirus was produced to induce the expression of TCP1 recombinant protein in transfected cells. Expression of recombinant protein in cells was confirmed by Western blot (FIG. 6).

As a result, as shown in Figure 6, it was confirmed that the expression of the systemic lupus erythematosus biomarker TCP1 was well induced.

Example  4: Systemic lupus erythematosus Biomarker  refine

TCP1 Baculovirus prepared for large-scale purification of systemic lupus erythematosus biomarker protein was secondaryly infected with SF9 insect host cells. Expression of TCP1 recombinant protein was induced to be purified using GST-tag contained in the bacmid.

SF9 insect cells secondarily infected with Baculovirus were incubated at 28 ° C. for 3 days. Afterwards, the virus-containing medium was centrifuged at 1500 rpm, stored at 4 ° C., and cells overexpressed with recombinant protein were washed once with PBS to remove residual medium. Cells were harvested by centrifugation at 1500 rpm for 1 minute, and 5 ml of cell lysis buffer (25 mM Tris-Cl (pH7.4), 150 mM NaCl, 1 mM EDTA, 1 mM DTT, 1% per 75T flask) into cells. NP-40, 0.1% Triton X-100, 1 mM PMSF, 1X protease inhibitor cocktail) were mixed and reacted at 4 ° C. for 30 minutes. The lysate was centrifuged at 14000 rpm for 10 minutes to recover only the supernatant. In order to purify only GST-TCP1 from aqueous solution, it was reacted with glutathione Sepharose 4B (GEHealthcare Life Science, USA). Thereafter, glutathione Sepharose 4B bound to the recombinant protein was isolated using a chromatography method. Wash three times with cell lysis buffer for removal of nonspecifically bound proteins. Recombinant proteins were eluted from glutathione Sepharose 4B using a solution containing 50 mM HEPES, 100 mM NaCL, 30% Glycerol and 40 mM GSH at pH 7.5.

Analysis by SDS-PAGE confirmed that about 70 kDa GST-TCP1 recombinant protein was purified (FIG. 7).

Example 5: Verification of Systemic Lupus Erythematosus

Dot blot assay was performed using purified GST-TCP1 recombinant protein to verify the presence of a large amount of newly discovered TCP1 autoantibodies in the serum of systemic lupus erythematosus patients. 1 μg of GST-TCP1 protein was accumulated on the NC membrane, and a dot blot assay was performed by reacting with serum of 50 normal and 48 systemic lupus erythematosus patients.

As a result, it was confirmed that TCP1 autoantibodies recognizing TCP1 autoantigens in serum of 27 patients were overexpressed compared to the normal group (FIG. 8). By the same results as the protein microarray results, it was verified that TCP1 autoantibodies were present in the serum of systemic lupus erythematosus patients more than the normal group.

Example 6: Specificity Analysis of Systemic Lupus Erythematosus Biomarkers for Clinical Samples

To verify whether TCP1 autoantibodies in serum of systemic lupus erythematosus are specific for systemic lupus erythematosus Dot blot assay was performed using purified GST-TCP1 recombinant protein. 1 μg of GST-TCP1 protein was accumulated on NC membrane and reacted with serum from 25 patients with Rheumatoid arthritis, 30 patients with Systemic sclerosis and 15 patients with Behcet's disease. The assay was performed.

As a result, it was confirmed that TCP1 autoantibodies were not detected in 25 patients with Rheumatoid arthritis, 26 patients with Systemic sclerosis, and 11 patients with Behcet's disease (FIG. 9). That is, it was verified that TCP1 autoantibodies present in the serum of the patient were systemic lupus erythematosus specific.

The results of the Dot blot assay performed in Example 5 and Example 6 were analyzed using the imageJ program and then graphically shown (FIG. 10).

Example 7 Comparison of Detection Specificity of CCT3 and TCP1 for Systemic Lupus Erythematosus Samples

For comparative analysis of the previously reported systemic lupus erythematosus specific autoantibody with CCT3 and TCP1, recombinant protein CCT3 (NM_005998, human recmbinant protein, cat # TP321229, Origene, USA) and TCP1 purified in Example 4 were used. The frequency of detection of systemic lupus erythematosus-specific autoantibodies was compared and analyzed.

As a result, the autoantibody detection rate of TCP1 by TCP1 recombinant protein in systemic lupus erythematosus blood was remarkably superior to that of CCT3 autoantibodies by CCT3 recombinant protein (FIG. 11). This means that TCP1 and CCT3 are present in the same complex but act as different antigens, indicating that the expression level of TCP1 autoantibodies is relatively higher than that of CCT3 autoantibodies. That is, it can be seen that TCP1 of the present invention is very excellent as a systemic lupus erythematosus specific biomarker.

As described above in detail a specific part of the content of the present invention, for those skilled in the art, such a specific description is only a preferred embodiment, which is not limited by the scope of the present invention Will be obvious. Thus, the substantial scope of the present invention will be defined by the appended claims and their equivalents.

<110> AJOU UNIVERSITY INDUSTRY-ACADEMIC COOPERATION FOUNDATION <120> Diagnosis of Systemic Lupus Erythematosus Using TCP1          Autoantibodies <130> P19-B113 <150> KR 10-2018-0053278 <151> 2018-05-09 <160> 3 <170> KoPatentIn 3.0 <210> 1 <211> 556 <212> PRT <213> Artificial Sequence <220> TCP1 <400> 1 Met Glu Gly Pro Leu Ser Val Phe Gly Asp Arg Ser Thr Gly Glu Thr   1 5 10 15 Ile Arg Ser Gln Asn Val Met Ala Ala Ala Ser Ile Ala Asn Ile Val              20 25 30 Lys Ser Ser Leu Gly Pro Val Gly Leu Asp Lys Met Leu Val Asp Asp          35 40 45 Ile Gly Asp Val Thr Ile Thr Asn Asp Gly Ala Thr Ile Leu Lys Leu      50 55 60 Leu Glu Val Glu His Pro Ala Ala Lys Val Leu Cys Glu Leu Ala Asp  65 70 75 80 Leu Gln Asp Lys Glu Val Gly Asp Gly Thr Thr Ser Val Val Ile Ile                  85 90 95 Ala Ala Glu Leu Leu Lys Asn Ala Asp Glu Leu Val Lys Gln Lys Ile             100 105 110 His Pro Thr Ser Val Ile Ser Gly Tyr Arg Leu Ala Cys Lys Glu Ala         115 120 125 Val Arg Tyr Ile Asn Glu Asn Leu Ile Val Asn Thr Asp Glu Leu Gly     130 135 140 Arg Asp Cys Leu Ile Asn Ala Ala Lys Thr Ser Met Ser Ser Lys Ile 145 150 155 160 Ile Gly Ile Asn Gly Asp Phe Phe Ala Asn Met Val Val Asp Ala Val                 165 170 175 Leu Ala Ile Lys Tyr Thr Asp Ile Arg Gly Gln Pro Arg Tyr Pro Val             180 185 190 Asn Ser Val Asn Ile Leu Lys Ala His Gly Arg Ser Gln Met Glu Ser         195 200 205 Met Leu Ile Ser Gly Tyr Ala Leu Asn Cys Val Val Gly Ser Gln Gly     210 215 220 Met Pro Lys Arg Ile Val Asn Ala Lys Ile Ala Cys Leu Asp Phe Ser 225 230 235 240 Leu Gln Lys Thr Lys Met Lys Leu Gly Val Gln Val Val Ile Thr Asp                 245 250 255 Pro Glu Lys Leu Asp Gln Ile Arg Gln Arg Glu Ser Asp Ile Thr Lys             260 265 270 Glu Arg Ile Gln Lys Ile Leu Ala Thr Gly Ala Asn Val Ile Leu Thr         275 280 285 Thr Gly Gly Ile Asp Asp Met Cys Leu Lys Tyr Phe Val Glu Ala Gly     290 295 300 Ala Met Ala Val Arg Arg Val Leu Lys Arg Asp Leu Lys Arg Ile Ala 305 310 315 320 Lys Ala Ser Gly Ala Thr Ile Leu Ser Thr Leu Ala Asn Leu Glu Gly                 325 330 335 Glu Glu Thr Phe Glu Ala Ala Met Leu Gly Gln Ala Glu Glu Val Val             340 345 350 Gln Glu Arg Ile Cys Asp Asp Glu Leu Ile Leu Ile Lys Asn Thr Lys         355 360 365 Ala Arg Thr Ser Ala Ser Ile Ile Leu Arg Gly Ala Asn Asp Phe Met     370 375 380 Cys Asp Glu Met Glu Arg Ser Leu His Asp Ala Leu Cys Val Val Lys 385 390 395 400 Arg Val Leu Glu Ser Lys Ser Val Val Pro Gly Gly Gly Ala Val Glu                 405 410 415 Ala Ala Leu Ser Ile Tyr Leu Glu Asn Tyr Ala Thr Ser Met Gly Ser             420 425 430 Arg Glu Gln Leu Ala Ile Ala Glu Phe Ala Arg Ser Leu Leu Val Ile         435 440 445 Pro Asn Thr Leu Ala Val Asn Ala Ala Gln Asp Ser Thr Asp Leu Val     450 455 460 Ala Lys Leu Arg Ala Phe His Asn Glu Ala Gln Val Asn Pro Glu Arg 465 470 475 480 Lys Asn Leu Lys Trp Ile Gly Leu Asp Leu Ser Asn Gly Lys Pro Arg                 485 490 495 Asp Asn Lys Gln Ala Gly Val Phe Glu Pro Thr Ile Val Lys Val Lys             500 505 510 Ser Leu Lys Phe Ala Thr Glu Ala Ala Ile Thr Ile Leu Arg Ile Asp         515 520 525 Asp Leu Ile Lys Leu His Pro Glu Ser Lys Asp Asp Lys His Gly Ser     530 535 540 Tyr Glu Asp Ala Val His Ser Gly Ala Leu Asn Asp 545 550 555 <210> 2 <211> 24 <212> DNA <213> Artificial Sequence <220> <223> TCP1 WT F <400> 2 atggaggggc ctttgtccgt gttc 24 <210> 3 <211> 27 <212> DNA <213> Artificial Sequence <220> <223> TCP1 WT R <400> 3 tcacaaatcg ttaagggctc cagagtg 27

Claims (9)

Systemic lupus erythematosus (SLE) diagnostic composition comprising an antigen protein that specifically binds to TCP1 (T-complex polypeptide 1) autoantibodies.
According to claim 1, The TCP1 systemic lupus erythematosus diagnostic composition, characterized in that represented by the amino acid sequence of SEQ ID NO: 1.
Systemic lupus erythematosus (SLE) diagnostic kit comprising the composition of claim 1 or 2.
The kit for diagnosing systemic lupus erythematosus according to claim 3, wherein the kit diagnoses systemic lupus erythematosus by detecting TCP1 autoantibodies in a bodily fluid sample through an antigen-antibody binding reaction.
The systemic lupus erythematosus diagnostic kit according to claim 4, wherein the body fluid is blood, serum or plasma.
4. The kit for diagnosing systemic lupus erythematosus according to claim 3, which is an enzyme immunoassay (ELISA), dot blot assay or western blot assay kit.
Informational methods for diagnosing systemic lupus erythematosus (SLE), including the following steps:
(a) detecting a T-complex polypeptide 1 (TCP1) autoantibody in a biological sample isolated from the subject; And
(b) comparing the detected TCP1 autoantibody levels with a control.
8. The method of claim 7, wherein the biological sample is blood, serum or plasma.
The method of claim 7, wherein the TCP1 is an information providing method for diagnosing systemic lupus erythematosus, characterized in that represented by the amino acid sequence of SEQ ID NO: 1.

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